Devices, systems and methods for retracting, lifting, compressing, supporting or repositioning tissues or anatomical structures

• US 7,645,286 B2
• Filed: 12/22/2005
• Issued: 01/12/2010
• Est. Priority Date: 05/20/2005
• Status: Active Grant

• Current Assignee: Teleflex Life Sciences III LLC
• Original Assignee: NeoTract, Inc. (Teleflex Incorporated)
• Inventors: Welch, Jacqueline Nerney, Nagpurkar, Amik, Collinson, Michael, Vidal, Claude, Catanese, Joseph III, Redmond, Russell J., Makower, Joshua, Walke, Amrish Jayprakash, Lamson, Theodore Charles
• Primary Examiner(s): Ho; (Jackie) Tan-Uyen T.
• Assistant Examiner(s): ANDERSON, GREGORY A
• Application Number:
  US11/318,246
• Publication Number:
  US 20060265042A1
• Time in Patent Office: 1,482 Days
• Field of Search: 606/151, 606/232
• US Class Current: 606/151
• CPC Class Codes: A61B 17/00234 for minimally invasive surgery A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61B 17/0218 for minimally invasive surgery A61B17/0281, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61B 17/0401 Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors A61B17/0642 takes precedence; fixation devices for tendons or ligaments A61F2/0811
• CPC Class Codes: A61B 17/0467 Instruments for cutting sutures surgical cutting instruments A61B17/32
• CPC Class Codes: A61B 17/0469 Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
• CPC Class Codes: A61B 17/0482 Needle or suture guides guides for drills, pins or wire A61B17/17; for puncturing needles A61B17/3403
• CPC Class Codes: A61B 17/0487 Suture clamps, clips or locks, e.g. for replacing suture knots; Instruments for applying or removing suture clamps, clips or locks suture anchors A61B17/0401; wound clamps or clips A61B17/08; ligaturing clamps or clips A61B17/122
• CPC Class Codes: A61B 17/06109 Big needles, either gripped by hand or connectable to a handle
• CPC Class Codes: A61B 17/0625 the needle being specially adapted to interact with the manipulator, e.g. being ridged to snap fit in a hole of the manipulator A61B17/06109 takes precedence
• CPC Class Codes: A61B 17/3468 for implanting or removing devices, e.g. prostheses, implants, seeds, wires devices for implanting seeds A61M37/0069
• CPC Class Codes: A61B 17/3478 Endoscopic needles, e.g. for infusion biopsy needles A61B10/0233; catheters with injection needles A61M25/0067
• CPC Class Codes: A61B 17/42 Gynaecological or obstetrical instruments or methods ligaturing clamps or clips for the umbilical cord A61B17/122; curettage A61B17/320708; dilators A61M29/00
• CPC Class Codes: A61B 2017/00022 Sensing or detecting at the treatment site
• CPC Class Codes: A61B 2017/00274 Prostate operation, e.g. prostatectomy, turp, bhp treatment
• CPC Class Codes: A61B 2017/00792 Plastic surgery
• CPC Class Codes: A61B 2017/00796 Breast surgery
• CPC Class Codes: A61B 2017/00805 Treatment of female stress urinary incontinence
• CPC Class Codes: A61B 2017/0404 Buttons
• CPC Class Codes: A61B 2017/0409 Instruments for applying suture anchors for applying suture clamps, clips or locks A61B2017/0488
• CPC Class Codes: A61B 2017/0417 T-fasteners
• CPC Class Codes: A61B 2017/0419 : H-fasteners
• CPC Class Codes: A61B 2017/042 : plastically deformed during insertion
• CPC Class Codes: A61B 2017/0451 : Cams or wedges holding the suture by friction
• CPC Class Codes: A61B 2017/0454 : the anchor being crimped or clamped on the suture
• CPC Class Codes: A61B 2017/0456 : Surface features on the anchor, e.g. ribs increasing friction between the suture and the anchor
• CPC Class Codes: A61B 2017/0458 : Longitudinal through hole, e.g. suture blocked by a distal suture knot
• CPC Class Codes: A61B 2017/0462 : One way system, i.e. also tensioning the suture
• CPC Class Codes: A61B 2017/0464 : for soft tissue
• CPC Class Codes: A61B 2017/0488 : Instruments for applying suture clamps, clips or locks for applying suture anchors A61B2017/0409; for applying wound clamps A61B17/10; for applying ligaturing clamps or clips A61B17/128
• CPC Class Codes: A61B 2017/0496 : for tensioning sutures
• CPC Class Codes: A61B 2017/06052 : Needle-suture combinations in which a suture is extending inside a hollow tubular needle, e.g. over the entire length of the needle hollow suture needles A61B2017/061
• CPC Class Codes: A61B 2017/06176 : with protrusions, e.g. barbs
• CPC Class Codes: A61B 2018/00547 : Prostate
• CPC Class Codes: A61F 2002/041 : Bile ducts

Abstract

Devices, systems and methods for retracting, lifting, compressing, supporting or repositioning tissues, organs, anatomical structures, grafts or other structures within the body of human or animal subjects for the purpose of treating a diseases or disorders and/or for cosmetic or reconstructive purposes and/or for research and development purposes or other purposes.

Claims

1. A method for changing the shape or cross dimension of a lumen or cavity of a human or animal body, said method comprising the steps of:

providing a first anchor, a second anchor and a connecting member that extends between the first anchor and the second anchor;

implanting the first anchor at a first location whereby it engages tissue near the lumen or cavity;

placing the second anchor at a second location whereby it engages tissue near the lumen or cavity; and

positioning and tensioning the connecting member such that the connecting member remains outside of the lumen or cavity and sufficient force is exerted on the lumen or cavity to change to shape or cross dimension of the lumen or cavity;

wherein the lumen or cavity comprises the lumen of an urethra of a subject whose prostate is enlarged such that it has caused a constriction of the lumen of the urethra and wherein the performance of the method results in less constriction of the lumen of the urethra by the enlarged prostate;

wherein the second anchor is constructed and implanted such that it becomes overgrown with tissue such that urine flowing through the lumen of the urethra does not directly contact the second anchor;

further comprising inserting a delivery device into the subject'"'"'s urethra, advancing a penetrator from the delivery device into or through the prostate gland so as to form a penetration tract that extends from the urethra, through prostate tissue and to the first location, delivering the first anchor with the connecting member attached through the penetration tract and causing the first anchor to become anchored at the first location such that the connecting member extends from the first anchor, through the penetration tract and into the urethra.

2. A method according to claim 1 wherein the first anchor is positioned to engage an exterior portion of the prostate and the second anchor is positioned to engage an interior portion of the prostate and wherein the tension on the connecting member relieves pressure on the urethra.

3. A method according to claim 2 wherein the first anchor is implanted such that it engages an outer aspect of the prostatic capsule.

4. A method according to claim 2 wherein the first anchor is implanted such that it is within the prostatic capsule.

5. A method according to claim 2 wherein the first anchor is implanted such that it engages prostate tissue located inside the prostatic capsule.

6. A method according to claim 2 wherein the second anchor is implanted within the urethra.

7. A method according to claim 2 wherein the second anchor is implanted within the urethral wall.

8. A method according to claim 2 wherein the second anchor is implanted within prostate tissue located outside of the wall of the urethra.

9. A method for treating a condition in a human or animal subject wherein a tissue located adjacent to a lumen or cavity is exerting undesired pressure on the lumen or cavity tubular anatomical structure, said method comprising the step of:

implanting at least one anchor in the body of the subject adjacent to or within the tissue,

connecting a tensioning element to the at least one anchor such that the tensioning element is under tension and exerts a force that displaces the tissue away from the tubular anatomical structure;

wherein the lumen or cavity comprises the lumen of an urethra of a subject whose prostate is enlarged such that it has caused a constriction of the lumen of the urethra and wherein the performance of the method results in less constriction of the lumen of the urethra by the enlarged prostate;

wherein the second anchor is constructed and implanted such that it becomes overgrown with tissue such that urine flowing through the lumen of the urethra does not directly contact the second anchor;

further comprising inserting a delivery device into the subject'"'"'s urethra, advancing a penetrator from the delivery device into or through the prostate gland so as to form a penetration tract that extends from the urethra, through prostate tissue and to the first location, delivering the first anchor with the tensioning element attached through the penetration tract and causing the first anchor to become anchored at the first location such that the tensioning element extends from the first anchor, through the penetration tract and into the urethra.

10. A method according to claim 9 wherein a first anchor is positioned to engage an exterior portion of the prostate and the second anchor is positioned to engage an interior portion of the prostate and wherein the tension on the connecting member compress prostate tissue between the first and second anchors, thereby relieving pressure on the urethra.

11. A method according to claim 10 wherein the first anchor is implanted such that it engages an outer aspect of the prostatic capsule.

12. A method according to claim 10 wherein the first anchor is implanted such that it is within the prostatic capsule.

13. A method according to claim 10 wherein the first anchor is implanted such that it engages prostate tissue located inside the prostatic capsule.

14. A method according to claim 10 wherein the second anchor is implanted within the urethra.

15. A method according to claim 10 wherein the second anchor is implanted within the urethral wall.

16. A method according to claim 10 wherein the second anchor is implanted within prostate tissue located outside of the wall of the urethra.

17. A method according to claim 9 wherein the penetrator is advanced from the urethra, through the prostate to an extracapsular first location.

18. A method according to claim 9 wherein the first anchor comprises an elongate member that is initially deployed in a first orientation that is substantially parallel to an adjacent portion of the connector as it is advanced through the penetration tract and subsequently moves to a second orientation that is substantially perpendicular to the adjacent portion of the connector after it has become implanted at said first location.

19. A method according to claim 9, further comprising advancing the second anchor over the connector to the second location and causing the second anchor to become affixed to the connector at the second location.

20. A method for causing a desired alteration of volitional or non-volitional flow of a body fluid through a lumen of the body of a human or animal subject, said method comprising the steps of:

positioning an anchor at a first location whereby it engages tissue near the lumen and;

attaching said anchor to a tensioning member at a selected location on said tensioning member, said selected location being selected from a plurality of potential locations each of which will result in a different amount of tension on the tensioning member, said selected location resulting in an amount of tension that causes the desired alteration of volitional or non-volitional flow of a body fluid through the lumen;

wherein the lumen of an urethra of a subject whose prostate is enlarged such that it has caused a constriction of the lumen of the urethra and wherein the performance of the method results in less constriction of the lumen of an urethra by the enlarged prostate;

further comprising inserting a delivery device into the subject'"'"'s urethra, advancing a penetrator from the delivery device into or through the prostate gland so as to form a penetration tract that extends from the urethra, through prostate tissue and to the first location, delivering the anchor with the tensioning member attached through the penetration tract and causing the anchor to become anchored at the first location such that the tensioning member extends from the anchor, through the penetration tract and into the urethra.

21. A method according to claim 20 wherein a first anchor having the tensioning element attached thereto is implanted to engage an exterior portion of the prostate and a second anchor is then advanced over the tensioning element and affixed to the tensioning element at a selected location whereby the second anchor engages an interior portion of the prostate and the tensioning element is under sufficient tension to compress prostate tissue between the first and second anchors, thereby relieving interference with normal micturition.

22. A method according to claim 21 wherein the first anchor is implanted such that it engages an outer aspect of the prostatic capsule.

23. A method according to claim 21 wherein the first anchor is implanted such that it is within the prostatic capsule.

24. A method according to claim 21 wherein the first anchor is implanted such that it engages prostate tissue located inside the prostatic capsule.

25. A method according to claim 21 wherein the second anchor is implanted within the urethra.

26. A method according to claim 21 wherein the second anchor is implanted within the urethral wall.

27. A method according to claim 21 wherein the second anchor is constructed and implanted such that it become overgrown with tissue such that urine flowing through the lumen of the urethra does not directly contact the second anchor.

28. A method according to claim 21 wherein the second anchor is implanted within prostate tissue located outside of the wall of the urethra.

29. A method for dilating, repositioning or changing the shape of a body lumen in a human or animal subject, said method comprising the steps of:

implanting two or more support members at spaced apart locations about the body lumen;

applying tension to at least some of the support members to create discrete and independent forces that result in dilation, repositioning or a change in shape of the body lumen

wherein the body lumen comprises the lumen of an urethra of a subject whose prostate is enlarged such that it has caused a constriction of the lumen of the urethra and wherein the performance of the method results in less constriction of the lumen of the urethra by the enlarged prostate;

further comprising inserting a delivery device into the subject'"'"'s urethra, advancing a penetrator from the delivery device into or through the prostate gland so as to form a penetration tract that extends from the urethra, through prostate tissue and to the first location, delivering at least one support member with a connector attached through the penetration tract and causing the at least one support member to become anchored at the first location such that the connector extends from the at least one support member, through the penetration tract and into the urethra.

30. A method according to claim 29 wherein tension is applied to at least some of the support members by attaching those support members to a tensioning member.

31. A method according to claim 29 wherein the method is carried out to facilitate urine flow through the lumen of the urethra of a subject whose prostate is enlarged.

32. A method according to claim 31 wherein at least one support member is positioned to support one lobe of the prostate and at least one support member is positioned to support the other lobe of the prostate.